【正文】 ISO9000:2000(E)ISO9000:2000(E)Quality management systems – Fundamentals and vocabulary1 ScopeThis International Standard describes fundamentals of quality management systems, which form the subject of the ISO 9000 family, and defines related terms.This International Standard is applicable to the following:a) organizations seeking advantage through the implementation of a quality management system。b) organizations seeking confidence from their suppliers that their product requirements will be satisfied。c) users of the products。d) those concerned with a mutual understanding of the terminology used in quality management (. suppliers, customers, regulators)。e) those internal or external to the organization who assess the quality management system or audit it for conformity with the requirements of ISO 9001 (. auditors, regulators, certification/registration bodies)。f) those internal or external to the organization who give advice or training on the quality management system appropriate to that organization。g) developers of related standards.2 Fundamentals of quality management systems Rationale for quality management systemsQuality management systems can assist organizations in enhancing customer satisfaction.Customers require products with characteristics that satisfy their needs and expectations. These needs and expectations are expressed in product specifications and collectively referred to as customer requirements. Customer requirements may be specified contractually by the customer or may be determined by the organization itself. In either case, the customer ultimately determines the acceptability of the product. Because customer needs and expectations are changing, and because of petitive pressures and technical advances, organizations are driven to improve continually their products and processes.The quality management system approach encourages organizations to analyse customer requirements, define the processes that contribute to the achievement of a product which is acceptable to the customer, and keep these processes under control. A quality management system can provide the framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other interested parties. It provides confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements. Requirements of quality management systems and requirements for productsThe ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.Requirements for quality management systems are specified in ISO 9001. Requirements for quality management systems are generic and applicable to organizations in any industry or economic sector regardless of the offered product category. ISO 9001 itself does not establish requirements for products.Requirements for products can be specified by customers or by the organization in anticipation of customer requirements, or by regulation. The requirements for products and in some cases associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements. Quality management systems approachAn approach to developing and implementing a quality management system consists of several steps including the following:a) determining the needs and expectations of customers and interested parties。b) establishing the quality policy and quality objectives of the organization。c) determining the processes and responsibilities necessary to attain the quality objectives。d) determining and providing the resources e) establishing methods to measure the effectiveness and efficiency of each process。f) applying these measures to determine the effectiveness and efficiency of each process。g) determining means of preventing nonconformities and eliminating their causes。h) establishing and applying a process for continual improvement of the quality management system.Such an approach is also applicable to maintaining and improving and existing quality management system.An organization that adopts the above approach creates confidence in the capability of its processes and the quality of its products, and provides a basis for continual improvement. This can lead to increased satisfaction of customers and other interested parties and to the success of the organization. The process approachAny activity, or set of activities, that uses resources to transform inputs to outputs can be considered as a process.For organizations to function effectively, they have to identify and manage numerous interrelated and interacting processes. Often, the output from one process will directly form the input into the next process. The systematic identification and management of the processes employed within an organization and particularly the interactions between such processes is referred to as the “process approach.”The intent of this International Standard is to encourage the adoption of the process approach to manage an organization. Figure 1 illustrates the processbased quality management system described the ISO 9000 family standards. This illustration shows that interested parties play a significant role in providing inputs to the organization. Monitoring the satisfaction of interested parties requires the evaluation of information relating to the perception of interested parties as to the extent to which their needs and expectations have been met. The model shown in Figure 1 does not show processes at a detailed level. Quality policy and quality objectivesQuality policy and quality objectives are established to provide a focus to direct the organization. Both determine the desired results and assist the organization to apply its resources to achieve these results. The quality policy provides a framework fo